Methods and systems for creating anatomical models

ABSTRACT

The disclosure herein includes methods for producing an anatomical model, which method may include: providing a mold assembly, which mold assembly may include: a first mold portion having an outer surface and an inner surface; and a second mold portion having an outer surface and an inner surface; disposing a lining material on either a portion of the inner surface of the first mold portion or a portion of the inner surface of the second mold portion, or both; forming a first cavity between the inner surface of the first mold portion and the inner surface of the second mold portion; positioning a portion of an insert in the first cavity; introducing a first material into the first cavity; removing a portion of the insert to expose a second cavity inside the mold assembly; and introducing a second material into the second cavity.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims benefit to co-pendingU.S. Non-Provisional application Ser. No. 15/152,948, filed on May 12,2016, which claims benefit to U.S. Provisional Application Ser. No.62/160,386, filed on May 12, 2015; and this application herebyincorporates herein those applications and all amendments thereto as ifset forth herein in their entireties.

BACKGROUND 1. Field of Inventions

The field of this application and any resulting patent is creation ofanatomical models.

2. Description of Related Art

Various methods and systems have been proposed and utilized to createanatomical models including the methods and systems disclosed in thereferences appearing on the face of this patent. However, these methodsand systems lack all the steps or features of the methods and devicescovered by the patent claims below. Furthermore, the methods and systemscovered by at least some of the claims of this issued patent may solvemany of the problems that prior art methods and systems have failed tosolve. Also, the methods and systems covered by at least some of theclaims of this patent may have benefits that would be surprising andunexpected to a person of ordinary skill in the art based on the priorart existing at the time of the inventions set forth in one or more ofthe claims herein.

SUMMARY

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) disposing a lining material oneither a portion of the inner surface of the first mold portion or aportion of the inner surface of the second mold portion, or both;forming a first cavity between the inner surface of the first moldportion and the inner surface of the second mold portion; 3) positioninga portion of an insert in the first cavity; 4) introducing a firstmaterial into the first cavity; 5) removing a portion of the insert toexpose a second cavity inside the mold assembly; and 6) introducing asecond material into the second cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) forming a first cavity betweenthe inner surface of the first mold portion and the inner surface of thesecond mold portion; 3) positioning a portion of an insert in the firstcavity; 4) introducing a first material into the first cavity to form abase model; 5) removing a portion of the insert from a surface of thebase model; 6) disposing a lining material on a portion of the surfaceof the base model; and 7) introducing a second material onto a portionof the lining material.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) disposing a lining material oneither a portion of the inner surface of the first mold portion or aportion of the inner surface of the second mold portion, or both; 3)forming a first cavity between the inner surface of the first moldportion and the inner surface of the second mold portion; 4) positioninga portion of an insert in the first cavity; 5) introducing a firstmaterial into the first cavity to form a base model, wherein the firstmaterial may interact with the first lining; 6) removing a portion ofthe insert to expose a second cavity inside the mold assembly; 7)disposing a second lining material on a surface of the base model; and8) introducing a second material into the second cavity, wherein thesecond material may interact with the second lining.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) disposing alining material on either a portion of the inner surface of the firstmold portion or a portion of the inner surface of the second moldportion, or both; 3) forming a first cavity between the inner surface ofthe first mold portion and the inner surface of the second mold portion;4) positioning a portion of the insert in the first cavity; 5)positioning a portion of the protrusion in the channel; 6) introducing afirst material through the opening into the first cavity to form a basemodel having an inner surface; 7) removing a portion of the insertthrough the channel to expose a second cavity inside the mold assembly;and 8) introducing a second material through the channel into a portionof the second cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) forming afirst cavity between the inner surface of the first mold portion and theinner surface of the second mold portion; 3) positioning a portion ofthe insert in the first cavity; 4) positioning a portion of theprotrusion in the channel; 5) introducing a first material through theopening into the first cavity to form a base model having an innersurface; 6) removing a portion of the insert through the channel toexpose a second cavity inside the mold assembly; 7) disposing a liningmaterial on a portion of the inner surface of the base model; and 8)introducing a second material through the channel into a portion of thesecond cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) disposing afirst lining material on either a portion of the inner surface of thefirst mold portion or a portion of the inner surface of the second moldportion, or both; 3) forming a first cavity between the inner surface ofthe first mold portion and the inner surface of the second mold portion;4) positioning a portion of the insert in the first cavity; 5)positioning a portion of the protrusion in the channel; 6) introducing afirst material through the opening into the first cavity to form a basemodel having an inner surface, wherein the first material interacts withthe first lining; 7) removing a portion of the insert through thechannel to expose a second cavity inside the mold assembly; 8) disposinga second lining material on a portion of the inner surface of the basemodel; and 9) introducing a second material through the channel into aportion of the second cavity, wherein the second material interacts withthe second lining.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first mold piece according to oneembodiment of the present disclosure, in which the first mold piece hasan inner surface covered by lining material.

FIG. 2 is a perspective view of a second mold piece according to oneembodiment of the present disclosure, in which the second mold piece hasan inner surface covered by lining material.

FIG. 3 is a perspective view of an insert according to one embodiment ofthe present disclosure.

FIG. 4 is a perspective, exploded view of a molding system made up ofthe pieces illustrated in FIGS. 1-3, configured to produce the basemodel and insert as displayed in FIGS. 7-9 in one embodiment of thepresent disclosure.

FIG. 5 is a perspective view of the molding system from FIG. 4 beingfilled with a suitable modeling material in one embodiment of thepresent disclosure.

FIG. 6 illustrates, in a center cross section, a perspective view of themolding system from FIG. 4 being filled with a suitable modelingmaterial in one embodiment of the present disclosure.

FIG. 7 is a perspective view of the base model and imbedded insert oneembodiment of the present disclosure.

FIG. 8 is a perspective view of the base model and imbedded insert inone embodiment of the present disclosure.

FIG. 9 is a perspective view of the base model and imbedded insert inone embodiment of the present disclosure.

FIG. 10 is a perspective view of the base model after removal of theimbedded insert, leaving a cavity in the volume where a feature isdesired in one embodiment of the present disclosure.

FIG. 11 illustrates in a perspective view of what the base model, afterremoval of the imbedded insert, would look like if split in half in oneembodiment of the present disclosure. The top and bottom pieces are infact one solid, continuous piece but are shown separated to illustratethe internal cavity.

FIG. 12 is a perspective view of the base model while the internalcavity in the base model is being filled with a material suitable tomodel the desired feature in one embodiment of the present disclosure.

FIG. 13 is a center cross section perspective view of the base modelwhere the internal cavity in the base model has been filled with amaterial suitable to model the desired feature and the channelconnecting the internal cavity to the outside of the model is beingfilled with the same material as the base model in one embodiment of thepresent disclosure.

FIG. 14 is a perspective view of the final product in one embodiment ofthe present disclosure. The dashed lines indicate an internal feature.

FIG. 15 illustrates in a perspective view what the final model,including internal feature, would look like if split in half in oneembodiment of the present disclosure. The top and bottom images are infact one solid, continuous piece but are shown separated to illustratethe internal cavity.

FIG. 16 is a flow diagram of the Anatomize Me process for creatinganatomy models from a computer model, including features different fromthe base model.

DETAILED DESCRIPTION 1. Introduction

A detailed description will now be provided. The purpose of thisdetailed description, which includes the drawings, is to satisfy thestatutory requirements of 35 U.S.C. § 112. For example, the detaileddescription includes a description of the inventions and sufficientinformation that would enable a person having ordinary skill in the artto make and use the inventions defined by the claims. The figures areintended to assist in the description and to provide visualrepresentations of certain aspects of the subject matter describedherein. The figures do not limit the scope of the claims.

Each of the appended claims defines a separate invention which, forinfringement purposes, is recognized as including equivalents of thevarious elements or limitations specified in the claims. Depending onthe context, all references below to the “invention” may in some casesrefer to certain specific embodiments only. In other cases, it will berecognized that references to the “invention” will refer to the subjectmatter recited in one or more, but not necessarily all, of the claims.Each of the inventions will now be described in greater detail below,including specific embodiments, versions, and examples, but theinventions are not limited to these specific embodiments, versions, orexamples, which are included to enable a person having ordinary skill inthe art to make and use the inventions when the information in thispatent is combined with available information and technology. Variousterms as used herein are defined below, and the definitions should beadopted when construing the claims that include those terms, except tothe extent a different meaning is given within the specification or inexpress representations to the Patent and Trademark Office (PTO). To theextent a term used in a claim is not defined below or in representationsto the PTO, it should be given the broadest definition persons havingskill in the art have given that term as reflected in printedpublications, dictionaries, and issued patents.

2. Selected Definitions

Certain claims include one or more of the following terms which, as usedherein, are expressly defined below.

The term “removable” as used herein is defined as capable of beingremoved from a particular spatial location, e.g., from a cavity or fromcontact with another object. A removable object, e.g., a removableinsert, is preferably capable of being separated from another objectwithout irreversibly compromising the shape or characteristics of thatother object. For example, a removable object entangled in anon-removable object may be formed of a material that is capable ofdissolving in a particular solvent, after which the dissolved materialmay be removed from the other object with which it was previouslyentangled. In contrast, the non-removable object can be a material thatis not capable of dissolving in that particular solvent. For example, aremovable object entangled in a non-removable object may comprise amaterial that has a first melting point, while the non-removable objectcomprises a material that has a melting point that is higher than thefirst melting point.

The term “insert” as used herein is defined as any physical object,preferably one that is artificial and has the shape of a feature that isbeing modeled, such as a tumor. An insert is preferably an object thatis capable of being positioned at least partially inside or within acavity or another object, e.g., the model of an organ. An insert mayalso be inside a cavity or other object, i.e., after it has been placedtherein. An insert may be partially or wholly removable. An insert maycomprise one or more portions. An insert may comprise a first portion, asecond portion, a third portion, and so forth. An insert comprising afirst portion and a second portion may exist as two separate anddistinct objects that are not coupled to one another. An insertcomprising a first portion and a second portion may be such that thefirst portion is removable, and the second portion is not removable. Aninsert comprising a first portion and a second portion may be such thatboth portions are removable (e.g., capable of being liquefied), and thefirst portion and the second portions are capable of being removedseparately or simultaneously. An insert may comprise an elongatedstructure capable of engaging with a corresponding elongated channel ina mold. An insert may be capable of being produced by layering. Aninsert may be capable of being positioned within a cavity such that theinsert is fixed in location with respect to the cavity. An insert may becapable of being liquefied.

The term “material” as used herein is defined as any liquid, solid, orsemi-solid substance, composition, or mixture. A material may comprise amixture of two or more materials. A first material may be identical to asecond material and/or a third material. Alternatively, a first materialmay be different from a second or a third material. A first material maycomprise different volumes or concentrations of various compounds orstructures as those found in a second material or a third material. Forexample, a first material may comprise 80% silicone, while a secondmaterial may comprise 90% silicone. A material may comprise, forexample, a combination containing some or all of the following: resins,plastics, polymers, rubber, oils, and dyes. For example, a material maycomprise platinum-cured silicone rubber such as Dragon Skin® 10A Fast. Amaterial may comprise a silicone thinner. A material may have a shorehardness between 0A, 5A, 10A, or 15A to 10A, 15A, 20A, 25A, or 30A asmeasured by ASTM test D-2240. A material may have a tensile strength at100% elongation ranging from a low of 100, 150, 200, 250, 300, or 400psi to 250, 300, 350, 400, 500, or 600 psi as measured by ASTM testD-412. The material may have a tensile stress at 100% elongation rangingfrom a low of 5, 10, 15, 25, 40, 50, or 60 psi to a high of 40, 50, 60,75, 80, 90, or 100 psi as measured by ASTM test D-412. Additionally, amaterial may be, e.g. wax, paraffin, solvent, solute, dye, and/oradhesive.

The term “lining material” as used herein is defined as any materialdisposed on a surface or structure, e.g. mold portion, base model,and/or pathology model. A portion of lining material may inhibit aportion of material from curing. A portion of the lining material maybond to a portion of another material. A portion of lining material maymix with a portion of another material. A portion of lining material mayreact to a portion of another material. A portion of lining material maydissolve a portion of another material. A portion of lining material maybe dissolved by a portion of another material. A portion of liningmaterial may cause a portion of another material to harden. A portion oflining material may cause a portion of another material to soften. Aportion of lining material may cause a portion of another material tochange color. A lining material may be a thin layer, e.g., film,coating, sheet, surface, covering, blanket, skin, and veneer. A liningmaterial may have a thickness of as little as a few molecules, 1 μm, 2μm, 3 μm, 4 μm, or 5 μm to as much as 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm,or even thicker. A lining material may be solid. The lining material maybe porous.

The term “interact” as used as a verb herein is defined as affect orcause change to and/or to be affected or changed by a thing, e.g.matter, fields, atomic particles, and/or subatomic particles. Forexample, a lining material may interact with material of an object,e.g., mold portion, base model, and pathology models. Change may bephysical or chemical. A first material may interact with a secondmaterial via physical and/or chemical phenomena including, solution,reaction, conduction, induction, gravitation, and electromagnetism.

The term “data set” as used herein is defined as computer-readableinformation. A data set may comprise three-dimensional data. A data setmay be derived from a patient's MRI data, CT data, and/or 3D ultrasounddata. A data set may be derived from information collected and assembledin electronic form.

The term “structure” as used herein is defined as any physical object.An anatomical structure may be a physical object having the same shapeas some part of the anatomy of a living being, such as an organ,implant, or other natural or artificial body part of an organism, humanor otherwise. A pathological structure may be any physical objectrelated to a disease of the body. Exemplary pathological structuresinclude tumors, growths, embolisms, inflamed tissues, diseased organs,and arterial deformities or blockages. An elongated structure may be astructure having at least one side longer than another side, asexemplified in the drawings herein. For example, an elongated structuremay comprise a hollow or non-hollow cylinder, a hollow or non-hollowprism, a tubular structure, or a protrusion. An elongated structure mayhave one or more curved sides.

The term “cavity” as used herein is defined as any hollow space withinan object or on an object's surface. A cavity may have various objectsor material positioned within its space. For example, a cavity may havean uncured resin or polymer positioned within it. A cavity may have morethan one object within its space. For example, an insert may be inside acavity and simultaneously a material may also be inside the cavity. Acavity may be formed when an object is removed from another object. Acavity may be shaped to correspond to a first object when the firstobject is removed from a second object. A cavity may be specificallydesigned to correspond to an anatomical structure.

The term “model” as used herein is defined as a representation,preferably of a specific object or structure. A model may refer to aphysical model which is capable of being touched and which might be arepresentation of a particular human organ, for example. A model mayrefer to a computer model that is a visual representation ofmathematical data, e.g., a three-dimensional computer rendering. Ananatomical model may be a representation of an anatomical structure. Amodel may be a computer model of a mold and might be referred to hereinas a “mold model.” A base model may comprise a model to which otherstructures, parts, or models may be added. A base model may comprise amodel to undergo further processes prior to its completion withoutadding other structures. For example, a base model comprising aremovable insert may be processed to remove the insert. A model(physical and/or computer) may be derived from three-dimensional imagingdata, e.g., MRI data. A model (physical and/or computer) may be derivedfrom two-dimensional imaging data, e.g., MRI slice data. A physicalmodel may be formed from a mold.

The term “mold” as used herein is defined as a structure having acavity, and in certain embodiments, the mold may be an anatomicalrepresentation.

The term “liquefy” as used herein is defined as to either becomepartially or fully a liquid or to cause something to become partially orfully a liquid. For example, heating certain types of material may causethose materials to melt and thus liquefy or become liquefied, in whichcase the act of heating the material is also liquefying the material.For example, certain materials may be soluble in certain solvents andthus liquefy, in which case the act of dissolving the material is alsoliquefying the material.

The term “remove” as used herein is defined as move from, and examplesof removing things in this application include removing inserts bymelting or dissolving the insert, followed by moving the liquefiedinsert, that is, a melted or dissolved insert material, away from alocation inside the cavity to a location outside the cavity. Anotherexample of removing something includes physical dislocation, such as aninsert that can be manually separated from a base model by theapplication of physical force.

The term “corresponds to” as used herein is defined as related to orassociated with, e.g., be similar, analogous, or equivalent to. Forexample, a mold may correspond to an anatomical structure if the cavityin the mold is shaped to resemble the anatomical structure. For example,an insert may correspond to a feature of an anatomical structure, e.g.,a tumor or vasculature, if the insert is partially shaped or formed toresemble the tumor. For example, an elongated structure may correspondto an elongated channel when the elongated structure fits into theelongated channel and is prevented from rotating. Two puzzle pieces maybe considered to correspond to one another. For example, an anatomicalstructure, e.g., a kidney having a tumor positioned inside a human body,may correspond to imaging data, e.g., from an MRI or CAT scan, if theimaging data was produced by scanning the anatomical structure.

The term “feature” as used herein is defined as a part or characteristicof some other part of a model and/or anatomy. A pathological feature isa feature that is pathological in nature, e.g., is cause by or involvesdisease. For example, a tumor may be a feature of a kidney.

The term “modify” as used herein is defined as to change somewhat ordrastically the form or qualities of something.

The term “channel” as used herein is defined as a groove or otherindentation on a surface of an object. Different channels may havedifferent shapes and geometries. For example, one of the channels in thedrawings has a rectangular cross-section, while another has a rounded orelliptical cross-section. Other channels may have yet different crosssections or have cross-sections that are different in shape or size evenfor a single channel.

The term “derived from” as used herein is defined as the state of onething that originates from another thing, or that owes its existence tosomething else.

The term “layering” as used herein is defined as any process thatinvolves placing or removing at least one layer of material on or from asurface, which may be another layer, and may also include successivelayering, which is placing or removing one layer on or from anotherlayer, and then placing or removing another layer on or from the layerthat was most recently placed or removed, etc. Two examples of processesthat involve successive layering are three-dimensional printing andlaser cutting.

3. Certain Specific Embodiments

Now, certain specific embodiments are described, which are by no meansan exclusive description of the inventions. Other specific embodiments,including those referenced in the drawing, are encompassed by thisapplication, and any patent that issues therefrom.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) disposing a lining material oneither a portion of the inner surface of the first mold portion or aportion of the inner surface of the second mold portion, or both;forming a first cavity between the inner surface of the first moldportion and the inner surface of the second mold portion; 3) positioninga portion of an insert in the first cavity; 4) introducing a firstmaterial into the first cavity; 5) removing a portion of the insert toexpose a second cavity inside the mold assembly; and 6) introducing asecond material into the second cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) forming a first cavity betweenthe inner surface of the first mold portion and the inner surface of thesecond mold portion; 3) positioning a portion of an insert in the firstcavity; 4) introducing a first material into the first cavity to form abase model; 5) removing a portion of the insert from a surface of thebase model; 6) disposing a lining material on a portion of the surfaceof the base model; and 7) introducing a second material onto a portionof the lining material.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; and b) a second mold portion having anouter surface and an inner surface; 2) disposing a lining material oneither a portion of the inner surface of the first mold portion or aportion of the inner surface of the second mold portion, or both; 3)forming a first cavity between the inner surface of the first moldportion and the inner surface of the second mold portion; 4) positioninga portion of an insert in the first cavity; 5) introducing a firstmaterial into the first cavity to form a base model, wherein the firstmaterial may interact with the first lining; 6) removing a portion ofthe insert to expose a second cavity inside the mold assembly; 7)disposing a second lining material on a surface of the base model; and8) introducing a second material into the second cavity, wherein thesecond material may interact with the second lining.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) disposing alining material on either a portion of the inner surface of the firstmold portion or a portion of the inner surface of the second moldportion, or both; 3) forming a first cavity between the inner surface ofthe first mold portion and the inner surface of the second mold portion;4) positioning a portion of the insert in the first cavity; 5)positioning a portion of the protrusion in the channel; 6) introducing afirst material through the opening into the first cavity to form a basemodel having an inner surface; 7) removing a portion of the insertthrough the channel to expose a second cavity inside the mold assembly;and 8) introducing a second material through the channel into a portionof the second cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) forming afirst cavity between the inner surface of the first mold portion and theinner surface of the second mold portion; 3) positioning a portion ofthe insert in the first cavity; 4) positioning a portion of theprotrusion in the channel; 5) introducing a first material through theopening into the first cavity to form a base model having an innersurface; 6) removing a portion of the insert through the channel toexpose a second cavity inside the mold assembly; 7) disposing a liningmaterial on a portion of the inner surface of the base model; and 8)introducing a second material through the channel into a portion of thesecond cavity.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: 1) providing a mold assembly, whichmold assembly may include: a) a first mold portion having an outersurface and an inner surface; b) a second mold portion having an outersurface and an inner surface; c) a channel extending through either thefirst mold portion or the second mold portion, or both; d) an openingextending through either the first mold portion or the second moldportion, or both; and e) an insert having a protrusion; 2) disposing afirst lining material on either a portion of the inner surface of thefirst mold portion or a portion of the inner surface of the second moldportion, or both; 3) forming a first cavity between the inner surface ofthe first mold portion and the inner surface of the second mold portion;4) positioning a portion of the insert in the first cavity; 5)positioning a portion of the protrusion in the channel; 6) introducing afirst material through the opening into the first cavity to form a basemodel having an inner surface, wherein the first material interacts withthe first lining; 7) removing a portion of the insert through thechannel to expose a second cavity inside the mold assembly; 8) disposinga second lining material on a portion of the inner surface of the basemodel; and 9) introducing a second material through the channel into aportion of the second cavity, wherein the second material interacts withthe second lining.

One or more specific embodiments herein includes methods for producingan anatomical model, comprising providing a mold having a first cavityshaped to correspond to an anatomical structure, providing an insertinside the first cavity of the mold, positioning a first material intothe first cavity such that the first material forms a base model,removing at least one portion of the insert from the mold to expose asecond cavity inside the mold, and positioning a second material into atleast a portion of the second cavity.

One or more specific embodiments herein includes methods for producingan anatomical model, comprising providing a mold having a first cavityshaped to correspond to an anatomical structure, wherein the moldcomprises at least one elongated channel, providing an insert inside thefirst cavity of the mold, wherein the insert comprises an elongatedstructure that corresponds at least partially to the elongated channel,positioning a first material into the first cavity to form a base model,removing at least one portion of the insert from the mold to expose asecond cavity inside the mold, and positioning a second material into atleast a portion of the second cavity. The mold, the insert, or both themold and the insert are produced by layering.

One or more specific embodiments herein includes methods for producingan anatomical model, comprising providing a mold having a first cavityshaped to correspond to an anatomical structure, providing an insertinside the first cavity of the mold, positioning a first material intothe first cavity to form a base model, liquefying at least one portionof the insert to form a liquid portion, removing the liquid portion toexpose a second cavity inside the mold, and positioning a secondmaterial into at least a portion of the second cavity.

One or more specific embodiments herein includes methods for producingan anatomical model comprising obtaining a computer model an anatomicalstructure for use with a computer-aided design program, modifying thecomputer model to produce a computer mold model, producing a mold fromthe computer mold model, the mold having a first cavity and an outersurface, producing an insert, positioning the insert in the first cavityof the mold, placing a first material into the first cavity of the moldand adjacent to the insert, permitting the first material to solidifywithin the mold, forming a base model, removing the insert from themold, thereby forming a second cavity in the mold, placing a secondmaterial into the second cavity of the mold, and permitting the secondmaterial to solidify.

One or more specific embodiments herein includes methods for producingan anatomical model comprising obtaining a first data set that forms ananatomical model corresponding to an anatomical structure of anorganism, deriving a second data set and a third data set from the firstdata set, wherein the second data set corresponds to a first feature ofthe anatomical structure and the third data set corresponds to a thirdfeature of the anatomical structure, deriving a fifth data set using thefirst data set and a fourth data set that forms a solid model that formsa computer mold model with a first cavity corresponding to theanatomical model, modifying the third data set to include an elongatedstructure, thereby forming a sixth data set, modifying the fifth dataset to include an elongated channel that corresponds at least partiallyto the elongated structure, thereby forming a seventh data set,producing an insert that corresponds to the sixth data set, producing amold that corresponds to the seventh data set, positioning the insertinside the mold, placing a first material in the mold, permitting thefirst material to solidify, removing the insert from the mold, therebyforming a second cavity in the mold, placing a second material in thesecond cavity, and permitting the second material to solidify.

One or more specific embodiments herein includes a system for use inproducing an anatomical model comprising a first insert that is shapedto correspond to an anatomical structure in a living organism, whereinthe first insert comprises a first material, and a mold that is shapedto correspond to the anatomical structure. The anatomical structurecomprises a pathological structure. The mold comprises a secondmaterial. At least 50% of the first material is capable of liquefyingunder conditions that do not liquefy 95% of the mold.

One or more specific embodiments herein includes a system for use inproducing an anatomical model comprising, a first insert that is shapedto correspond to a first feature of an anatomical structure, a secondinsert that is shaped to correspond to a second feature of theanatomical structure, and a mold that is shaped to correspond to theanatomical structure. The first insert and the second insert are capableof being fixed in position relative to the mold, thereby forming anassembled mold. The assembled mold is capable of containing a base modelformed from a first material. The first insert, the second insert, orboth the first and second inserts are capable of being liquefied andthen removed from the mold.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: providing a first portion of a moldhaving a first portion of a first cavity and a second portion of a moldhaving a second portion of the first cavity, wherein the first cavity,or the first portion of the first cavity, or the second portion of thefirst cavity, is shaped to correspond to an anatomical structure,wherein: the first portion of the mold and the second portion of themold each has an inner surface and an outer surface; and the firstportion of the mold, or the second portion of the mold, or both thefirst and second portions of the mold comprises a channel extending fromthe inner surface to the outer surface of the first portion of the mold,or of the second portion of the mold, or of both the first and secondportions of the mold; and an opening extending from the inner surface tothe outer surface of the first portion of the mold, or of the secondportion of the mold, or of both the first and second portions of themold; positioning an insert comprising a protrusion so that a portion ofthe insert is disposed inside the first portion of the first cavity ofthe mold, or inside the second portion of the first cavity of the mold,or inside both the first and second portions of the first cavity of themold, and wherein the protrusion, is disposed in the channel; bringingtogether the first portion of the mold with the second portion of themold to form the first cavity wherein at least a portion of the insertis disposed within the first cavity; introducing a first materialthrough the opening of the mold into the first cavity to form a basemodel, which opening extends from the inner surface to the outer surfaceof the first portion of the mold, or of the second portion of the mold,or of both the first and second portions of the mold; removing at leastone portion of the insert from the mold to expose a second cavity insidethe mold wherein removing at least a portion of the insert from the moldcomprises dissolving or melting the portion of the insert while thefirst material remains solidified; and introducing a second materialthrough the channel into at least a portion of the second cavity;wherein the mold, the insert, or both the mold and the insert areproduced by layering.

The disclosure herein includes methods for producing an anatomicalmodel, which method may include: providing a mold having a first cavityshaped to correspond to an anatomical structure, wherein the mold has aninner surface adjacent the first cavity and an outer surface andcomprises at least one elongated channel that is non-cylindrical sectionextending from the inner surface of the mold to the outer surface of themold and an opening extending from the inner surface to the outersurface of the mold; providing an insert inside the first cavity of themold wherein the insert includes an elongated structure that isnon-cylindrical and corresponds at least partially to the cross-sectionof the elongated channel, fits into the elongated channel, and extendsat least from the inner surface of the mold to the outer surface of themold; positioning a first material through the opening of the mold intothe first cavity to form a base model; liquefying at least one portionof the insert to form a liquid portion; removing the liquid portion toexpose a second cavity inside the mold; and positioning a secondmaterial through the groove of the mold into at least a portion of thesecond cavity.

In any of the methods or systems disclosed herein, three-dimensionaldata sets may be captured using magnetic resonance imaging (MRI),computerized tomography (CT), ultrasound (US), nuclear medicine, ormicroscopy techniques.

In any one of the methods or systems disclosed herein, the mold insertmay comprise polyvinyl alcohol (PVA), acrylonitrile butadiene styrene(ABS), and/or high-impact polystyrene (HIPS).

In any one of the methods or systems disclosed herein, the mold baseand/or the mold insert may comprise polylactic acid (PLA), ABS,plastics, polymers, rubbers, resins, and/or metals.

In any of the methods or systems disclosed herein, three-dimensionaldata set of an anatomical structure may be modified to simplify complexportions of the model that are unnecessary for its intended purpose.

In any of the methods or systems disclosed herein, three-dimensionaldata of an organ may be modified to remove connecting structures fromthe organ that are unnecessary for its intended purpose.

In any of the methods or systems disclosed herein, the material may bepressure injected into the mold.

In any of the methods or systems disclosed herein, the material may bepoured into the mold without additional external force.

In any of the methods or systems disclosed herein, a brace may bepositioned such that the brace extends into the first material and thesecond material.

In any of the methods or systems disclosed herein, the first materialmay have at least one property that is different from the secondmaterial including, but not limited to, shore hardness, tensilestrength, elasticity, rebound characteristics, density, dielectricproperties (permittivity and conductivity), sonographic properties,magnetic properties or color.

In any of the methods or systems disclosed herein, the mold may beprovided using additive manufacturing techniques, e.g.,three-dimensional printing techniques.

In any of the methods or systems disclosed herein, the mold may beprovided using subtractive manufacturing techniques.

In any of the methods or systems disclosed herein, the insert maycomprise a first insert portion and a second insert portion.

In any of the methods or systems disclosed herein, removing at least aportion of the insert from the mold may comprise removing the firstinsert portion.

Any one of the methods or systems disclosed herein may further compriseremoving another insert portion from the mold to form a third cavityinside the mold and positioning a third material into at least a portionof the third cavity.

In any of the methods or systems disclosed herein, the insert maycorrespond to one or more features of the anatomical structure.

Any one of the methods or systems disclosed herein may further comprisepositioning the first material into the second cavity such that thefirst material at least partially surrounds the second material.

In any of the methods or systems disclosed herein, positioning the firstmaterial into the first cavity such that the first material forms thebase model may comprise placing the first material in liquid form intothe first cavity and permitting the first material to solidify.

In any of the methods or systems disclosed herein, the anatomicalstructure may comprise a pathological structure.

In any of the methods or systems disclosed herein, removing at least aportion of the insert from the mold may comprise dissolving or meltingthe portion of the insert while the first material remains solidified.

In any of the methods or systems disclosed herein, providing a mold maycomprise producing the mold using a three-dimensional printer from acomputer mold model.

In any of the methods or systems disclosed herein, providing an insertinside the first cavity of the mold may comprise producing the insertusing a three-dimensional printer and positioning the insert inside thefirst cavity of the mold.

In any of the methods or systems disclosed herein, the first material,the second material, or both the first and second materials may have ashore hardness from 0 to 30 on the shore A scale after solidifying.

In any of the methods or systems disclosed herein, the insert maycomprise polyvinyl alcohol.

In any of the methods or systems disclosed herein, the mold may comprisea first section and a second section, and the first section and thesecond section are capable of being removably coupled to one another.

In any of the methods or systems disclosed herein, the elongatedstructure may be non-cylindrical.

In any of the methods or systems disclosed herein, the elongatedstructure may be a protrusion and the elongated channel is a groove.

In any of the methods or systems disclosed herein, the first materialmay comprise silicone rubber.

In any of the methods or systems disclosed herein, the anatomicalstructure may correspond to imaging data from an MRI or CAT scan.

In any of the methods or systems disclosed herein, the anatomicalstructure may comprise a first feature.

In any of the methods or systems disclosed herein, the second materialmay have at least one physical property that differs from that of thefirst material.

In any of the methods or systems disclosed herein, the computer modelmay be derived from patient MRI data or CAT scan data.

In any of the methods or systems disclosed herein, the computer modelmay be derived from a plurality of two-dimensional images.

In any of the methods or systems disclosed herein, modifying thecomputer model may comprise subtracting at least a portion of thecomputer model from a solid object model to obtain the computer moldmodel.

In any of the methods or systems disclosed herein, modifying thecomputer model to produce the computer mold model may comprise adding achannel extending from an inner surface of the computer mold model to anouter surface of the computer mold model.

In any of the methods or systems disclosed herein, the first materialmay have a conductivity between 0 and 10 S/m at a frequency of 13.5 MHzand an electric susceptibility between 25 and 500 after solidifying.

Any one of the methods or systems disclosed herein may further compriseliquefying the mold.

In any of the methods or systems disclosed herein, liquefying the insertmay comprise dissolving or melting the insert.

Any one of the methods or systems disclosed herein may further comprisea third insert that is capable of being fixed in position relative tothe mold, wherein the third insert is capable of being liquefied.

In any of the methods or systems disclosed herein, the first feature orthe second feature of an anatomical model may correspond to vasculaturestructures, bone structures, musculature structures, pathologicalstructures, or any other structure found in an organism.

Some specific embodiments herein may include a mold or system producedusing any of the processes described in this specification.

Any of the methods or systems disclosed herein may further includeintroducing the first material into the first cavity may includeintroducing the first material through an opening extending througheither the first mold portion or the second mold portion, or both.

In any of the methods or systems disclosed herein, the insert has aprotrusion having a portion disposed in a channel extending througheither the first mold portion or the second mold portion, or both.

Any of the methods or systems disclosed herein may further includeremoving the portion of the insert through a channel extending througheither the first mold portion or the second mold portion, or both.

Any of the methods or systems disclosed herein may further includeintroducing the first material through an opening extending througheither the first mold portion or the second mold portion, or both.

In any of the methods or systems disclosed herein, a portion of thelining material may inhibit a portion of the first material from curing.

In any of the methods or systems disclosed herein, a portion of thelining material may bond to a portion of the first material.

In any of the methods or systems disclosed herein, a portion of thelining material may mix with a portion of the first material.

In any of the methods or systems disclosed herein, a portion of thelining material may react to a portion of the first material.

In any of the methods or systems disclosed herein, a portion of thelining material may dissolve a portion of the first material.

In any of the methods or systems disclosed herein, a portion of thelining material may be dissolved by a portion of the first material.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the first material to harden.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the first material to soften.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the first material to changecolor.

In any of the methods or systems disclosed herein, the first cavity maybe formed by alignment of the inner surface of the first mold portionand the inner surface of the second mold portion.

In any of the methods or systems disclosed herein, removing the portionof the insert from the mold may include dissolving or melting theportion of the insert while the first material is solid.

In any of the methods or systems disclosed herein, removing the portionof the insert from the mold may be through the channel.

In any of the methods or systems disclosed herein, a portion of thelining material may inhibit a portion of the second material fromcuring.

In any of the methods or systems disclosed herein, a portion of thelining material may bond to a portion of the second material.

In any of the methods or systems disclosed herein, a portion of thelining material may mix with a portion of the second material.

In any of the methods or systems disclosed herein, a portion of thelining material may react to a portion of the second material.

In any of the methods or systems disclosed herein, a portion of thelining material may dissolve a portion of the second material.

In any of the methods or systems disclosed herein, a portion of thelining material may be dissolved by a portion of the second material.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the second material to harden.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the second material to soften.

In any of the methods or systems disclosed herein, a portion of thelining material may cause a portion of the second material to changecolor.

4. Specific Embodiments in the Figures

The drawings presented herein are for illustrative purposes only and arenot intended to limit the scope of the claims. Rather, the drawings areintended to help enable one having ordinary skill in the art to make anduse the claimed inventions. Various aspects of certain specificembodiments of methods for creating realistic anatomical models aredepicted. These methods have steps any one of which may be found invarious specific embodiments, including both those that are shown inthis specification and those that are not shown.

Referring to FIGS. 1-3, a bottom portion 10 and a top portion 11 of amold and an insert 17 are depicted. Three-dimensional data sets, such asCT or MRI data, may be used to produce a computer model of an anatomicalstructure. The three-dimensional data set may be from a particularpatient. Alternatively, a model may be created from scratch usingComputer Aided Design (CAD) software. For example, an implant to bepositioned within a patient may be sculpted and shaped from scratchusing a CAD program to the patient's and/or physician's specifications.An object to be modeled may utilize portions that require modelingmaterials having different characteristics, e.g., tensile strengths. Forexample, in the structures shown in FIGS. 1-3, MRI data of a patient'skidney having a tumor was used to produce the mold and insert 17. TheMRI data is preferably able to differentiate between different types oftissue, in this case, between the kidney and the tumor. MRI data may beprocessed in into a three-dimensional model using data interpretationsoftware such as 3D Slicer™.

Referring to FIG. 1, the bottom portion 10 may have an outer surface andan inner surface. The inner surface may have one or more planar portionsand one or more contoured portions. The one or more contoured portionsmay be protrusions or recesses on the inner surface. The one or morecontoured portions may have lining material 80 disposed thereon. The oneor more contoured portions may be covered by the lining material 80.

Referring to FIG. 2, the top portion 11 may have an outer surface and aninner surface. The inner surface may have one or more planar portionsand one or more contoured portions. The one or more contoured portionsmay be protrusions or recesses on the inner surface. The one or morecontoured portions may have lining material 80 disposed thereon. The oneor more contoured portions may be covered by the lining material 80.

The lining material 80 may be a thin layer, e.g., film, coating, sheet,surface, covering, blanket, skin, and veneer. The lining material 80 mayhave a thickness of as little as a few molecules, 1 μm, 2 μm, 3 μm, 4μm, or 5 μm to as much as 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm, or eventhicker. The lining material 80 may be solid. The lining material 80 maybe porous.

Additionally, an opening 36 may extend through the outer surface and theinner surface of the top portion 11.

In various versions, an opening 36 may be positioned in either the topportion 11 or the bottom portion 10, or both the top portion 11 andbottom portion 10. Thus, in some versions, an opening 36 may extendthrough an outer surface and an inner surface of a bottom portion 10.Moreover, the opening 36 may extend through lining material 80 disposedon an inner surface of the bottom portion 10. In other versions, the topportion 11 and bottom portion 10 may each have an opening 36 extendingtherethrough.

In FIG. 1 and FIG. 2, the bottom portion 10 and top portion 11 may becombined to form a cavity 13 that has the shape, e.g., the negativeshape, of a desired anatomical structure. The cavity walls may form theouter surface of the anatomical model that is to be produced. The bottomportion 10, the top portion 11, or both, may have one or more structuresor channels 22 with which an insert 17 can be oriented. The channel 22may be non-cylindrical in shape such that a corresponding shapepositioned in the channel 22 is not capable of rotating, whichfacilitates the proper orienting of insert 17 within the cavity 13. Thecavity 13 is formed when the top portion 11 and bottom portion 10 of themold are assembled, and the cavity 13 may, e.g. correspond to the kidneyplus the tumor.

The opening 36 may be positioned in the top portion 11 through whichliquefied material may be poured into the cavity 13 of the mold (seeFIG. 5).

In FIG. 3, the tumor shape 14 of the insert 17 may be shaped tocorrespond to a tumor structure in an organism. The insert 17 mayinclude an elongated structure 16 (e.g., a rectangular prism) that iscapable of being positioned in the channel 22 in the top portion 11and/or bottom portion 10 of the mold. The insert base may include anextension 19 that serves to assist in positioning the insert 17 in thecavity 13 of the mold. For example, the insert 17 may be positioned suchthat the extension 19 is immediately adjacent to a side wall (15, FIGS.1 and 2) of the top portion 11 and/or the bottom portion 10 of the mold.The elongated structure 16 and the extension 19 on the tumor base eachor both may cause the tumor shape 14 of the insert 17 to be positionedat a specific three-dimensional location with respect to the top portion11 and the bottom portion 10 of the mold. The insert 17 preferablycomprises PVA.

Referring to FIG. 4, a depiction of the mold 21 and the insert 17 isshown with the top portion 11, the bottom portion 10, and the insert 17oriented to be capable of fitting together. Additionally, liningmaterial 80 disposed on respective inner surfaces, e.g., contouredportion, of the top portion 11 and the bottom portion 10 may be aligned.When the top portion 11, bottom portion 10, and the insert 17 are fittogether, the void formed between the bottom and top portions 10, 11 andthe insert 17 may correspond to the kidney structure excluding thetumor.

Referring to FIG. 5 and FIG. 6, a depiction of the assembled mold 21with the insert 17 in place is shown as being filled with material 23.The material 23 may initially comprise a liquid, for example, a resin orsilicone-based substance. The extension 19 of the insert may bepositioned so as to ensure the insert shape 14 is correctly positionedat the desired location in the cavity 13. The weight of the top portion11 and the bottom portion 10 of the mold 21 on the extension 19 of theinsert may prevent unwanted movement of the insert while the material 23is being added to the mold.

Referring to FIG. 6, an inner surface, e.g., contoured portion, of thetop portion 11 may have first lining material 80 disposed thereon. Thefirst lining material 80 may cover some or all of the inner surface. Thematerial 23 disposed in the cavity 13 may physically touch the firstlining material 80. A portion of the first lining material 80 mayinhibit a portion of the material 23 from curing. A portion of the firstlining material 80 may bond to a portion of the material 23. A portionof the first lining material 80 may mix with a portion of the material23. A portion of the first lining material 80 may react to a portion ofthe material 23. A portion of the first lining material 80 may dissolvea portion of the material 23. A portion of the first lining material 80may be dissolved by a portion of the material 23. A portion of the firstlining material 80 may cause a portion of the material 23 to harden. Aportion of the first lining material 80 may cause a portion of thematerial 23 to soften. A portion of the first lining material 80 maycause a portion of the material 23 to change color.

Although not shown, it should be understood that a bottom portion 10 mayhave an inner surface having first lining material 80 disposed thereon.Moreover, the first lining material 80 may interact with the material 23as discussed above.

Referring to FIGS. 7, 8, and 9, a depiction of a kidney base model 40formed from the first material is shown with the elongated structure 16and extension 19 of the insert protruding from the kidney base model 40.After the material has solidified within the mold, the top portion andthe bottom portion of the mold are separated, and the kidney base model40 is removed from the mold. The insert remains in the mold as depicted.Alternatively, the insert may be removed while the kidney base model 40is still in the mold. Preferably, the insert is prevented from shiftingwithin the kidney base model 40 as a result of the extension 19 and/orelongated structure 16 until the kidney base model 40 becomes fullysolid, which subsequently locks the insert in place.

Referring to FIG. 10 and FIG. 11, a depiction of the kidney base model40 formed from the first material 23 is shown after the insert has beenremoved. The insert may be removed by dissolving the insert in a fluid,then removing the liquefied insert material. For example, a kidney basemodel 40 with an insert comprising PVA embedded in it may be placed inwater to dissolve the insert. Once dissolved, the kidney base model 40with its newly formed cavity 45 can be removed from the PVA-in-watersolution, and the solution poured from the cavity 45. Also, for example,a kidney base model 40 with an insert comprising one or more polymers orplastics may be placed in acetone or fluids with similar characteristicsto dissolve the insert. For example, an insert having a melting pointbelow that of the first material may be heated until liquefied andremoved from the kidney base model 40. The kidney base model 40 with theinsert inside may be placed in a volume of liquid which is heated and/oragitated as needed depending on the composition of the insert. Theremoval of the insert may result in a cavity 45 within the kidney basemodel 40. Although the kidney base model 40 is depicted as two halves inFIG. 11, preferably the kidney base model 40 is a single piece ofsilicone mixture. FIG. 11 is presented to demonstrate the shape of thecavity 45 remaining after removal of the insert. In addition to thecavity 45, there may also be a channel 60 produced by removal of theelongated structure of the insert. The channel 60 may extend fromoutside of the kidney base model 40 to the cavity 45 formed by removalof the insert. The channel 60 may or may not correspond to a tumorportion of the model, i.e., it may or may not have been added to thetumor-shaped model prior to formation of the insert.

Referring to FIG. 11, respective inner surfaces, e.g., contouredportions, of the bottom portion 10 and/or top portion 11 may have secondlining material 82 disposed thereon. The second lining material 82 maycover some or all of the inner surface of the kidney base model 40. Thematerial 23 forming the kidney base model 40 may physically touch thesecond lining material 82.

The second lining material 82 may be a thin layer, e.g., film, coating,sheet, surface, covering, blanket, skin, and veneer. The second liningmaterial 82 may have a thickness of as little as a few molecules, 1 μm,2 μm, 3 μm, 4 μm, or 5 μm to as much as 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm,or even thicker. The second lining material 82 may be solid. The secondlining material 82 may be porous.

A portion of the second lining material 82 may inhibit a portion of thematerial 23 from curing. A portion of the second lining material 82 maybond to a portion of the material 23. A portion of the second liningmaterial 82 may mix with a portion of the material 23. A portion of thesecond lining material 82 may react to a portion of the material 23. Aportion of the second lining material 82 may dissolve a portion of thematerial 23. A portion of the second lining material 82 may be dissolvedby a portion of the material 23. A portion of the second lining material82 may cause a portion of the material 23 to harden. A portion of thesecond lining material 82 may cause a portion of the material 23 tosoften. A portion of the second lining material 82 may cause a portionof the material 23 to change color.

Referring to FIG. 12 and FIG. 13, a second material 42 is being pouredinto the cavity 45 formed by removal of the insert. The tumor model 72may be formed after removing the tumor-shaped insert by pouring a secondmaterial 42 into the cavity 45 remaining after removal of the insert.The channel 60 provides an entrance hole in the kidney base model 40through which the second material 42 may be poured. When a tumor model72 is completely internal to the kidney model 40 as is pictured in thefigures, an elongated structure may be added to the insert to form achannel, for example as seen in FIG. 3. When a tumor model 72 is atleast partially external from the kidney model, a channel through thekidney base model 40 may not be needed. In this case, the kidney basemodel 40 may still be contained in the mold, and the mold may correspondto portions of the exterior of the feature (e.g., tumor) after theinsert is dissolved.

Referring to FIG. 13, an inner surface, e.g., contoured portion, of thekidney base model 40 may have second lining material 82 disposedthereon. The second lining material 82 may cover some or all of theinner surface of the kidney base model 40. One or more portions of thesecond lining material 82 may interact with the material 23 forming thekidney base model 40 (similar to interactions between the material 23and the second lining material 80 discussed above).

In addition, the second material 42 forming the tumor model 72 mayphysically touch the second lining material 82. A portion of the secondlining material 82 may inhibit a portion of the second material 42 fromcuring. A portion of the second lining material 82 may bond to a portionof the second material 42. A portion of the second lining material 82may mix with a portion of the second material 42. A portion of thesecond lining material 82 may react to a portion of the second material42. A portion of the second lining material 82 may dissolve a portion ofthe second material 42. A portion of the second lining material 82 maybe dissolved by a portion of the second material 42. A portion of thesecond lining material 82 may cause a portion of the second material 42to harden. A portion of the second lining material 82 may cause aportion of the second material 42 to soften. A portion of the secondlining material 82 may cause a portion of the second material 42 tochange color.

Referring to FIG. 14 and FIG. 15, a final kidney-tumor model isdepicted, wherein the tumor model 72 is entirely encased by the kidneymodel 40. After removing the insert and adding the second material, thesecond material may be permitted to solidify. Once solidified, thesecond material does not completely fill the channel because the tumordoes not extend to the surface of the kidney. The first material maythen be used to fill the remaining portion of the channel such that thefirst material completely encases the second material.

Referring to FIG. 16, a block diagram of the steps of one specificembodiment of the methods claimed herein is depicted. The block diagramserves to illustrate the manner in which a mold having multipleremovable inserts may be processed.

5. Additional Specific Embodiments

One or more specific embodiments, which may include aspects in commonwith the earlier reference specific embodiments, are now described. Incertain specific embodiments, the goal of this process is to createlifelike models of anatomy and implants (referred to herein as the“Anatomize Me” process) which can rapidly be custom built to desiredspecifications. The Applicant's process allows for rapidly producedmodels that look and feel real. In embodiments these physical models arebased on a patient's actual anatomy, and in other embodiments aredesigned as desired.

A model creation process embodying the present invention utilizes, as aninput to the process, a 3D computer model. The Anatomize Me processcreates a physical model from this computer model. In at least oneembodiment, this computer model contains one or more volumes withdifferent physical properties or coloration from the base model(hereafter to be referred to as features). In at least one embodiment,the computer model is based on medical scan data from an individualpatient and is used to practice that patient's surgery.

In one embodiment, the input 3D computer model comprises a kidney and atumor inside the kidney, modeled based on a patient's Magnetic ResonanceImaging (MRI) or Computed Tomography (CT) data. In this embodiment theAnatomize Me process produces a physical model of the patient's kidneywith an imbedded tumor which can be used to practice excising thepatient's tumor in robotic assisted surgery. The Anatomize Me processfor this embodiment is illustrated in FIGS. 1-15.

In a different embodiment, the input 3D computer model consists of acomputer model of a patient's foot, and the Anatomize Me processproduces a physical 3D model of the patient's foot containing a hardinternal structure mimicking the patient's bone, a soft volume aroundthe bone modeling the patient's muscle and connective tissue, and aninternal volume modeling the patient's vasculature inside the foot.

In a different embodiment, the Anatomize Me process is used to create alife-like model of a heart, including empty spaces inside thevasculature where appropriate.

In a different embodiment, the present invention is used to create amodel of a human spinal column, including bone, nerves, and discs foruse in the training of medical professionals.

In a different embodiment, the present invention is used to create amodel ear in one solid piece which may be used by the patient forcosmetic reasons in the case of a lost ear.

The Anatomize Me process is conducted as follows. Using Computer AidedDesign (CAD) software, a 3D computer model of the desired anatomy isused to create a 3D computer model of a mold of the desired anatomy. Inone embodiment, this is achieved by importing the input data into a CADprogram, combining all parts of the model, and then subtracting theresult from a solid block. This mold may be split into two or morepieces to eventually allow for easier de-molding and re-use of the mold.A channel is added to one or more pieces of the computer model of themold to allow for the interior to be filled. Features, if desired, aredesigned as separate pieces containing channels that run to the outsideof the mold and that fit together with the mold (hereafter referred toas inserts).

Once the computer 3D model is complete, rapid prototyping techniques areused to create the mold and inserts. In at least one embodiment, 3Dprinting is used to create the mold and any inserts. In otherembodiments, laser cutting, other rapid prototyping techniques, or acombination of rapid prototyping techniques are used to create the moldand inserts. In different embodiments, the base model may be created outof many possible materials, including (but not limited to) PolylacticAcid (PLA), Acrylonitrile butadiene styrene (ABS), other plastics,resins, and metals. Two types of inserts may be used. Removable insertsare manufactured out of a material that is dissolvable or otherwiseremovable from the base model, including but not limited to ABS,Polyvinyl alcohol (PVA) and High Impact Poly-Styrene (HIPS).Non-removable inserts may be made out of any of the materials listed aspossible base materials.

After their construction, the mold and inserts are fitted together. Themold is then filled with a suitable material for creating the desiredcharacteristics of the base model. Materials that could be used for thebase model include but are not limited to silicone gels, hydrogels,plastics, rubbers, silicone rubbers, elastomers and composite materials.After setting, the mold is removed, leaving the base model with anyinserts imbedded in or touching the base model.

Next, one or more removable insert (if any are included in the design)are removed using a suitable technique. In one embodiment, ABS removableinserts are dissolved in acetone. In another embodiment, removable PVAinserts are dissolved in boiling water. In a third embodiment, removableHIPS is dissolved in limonene. In a fourth embodiment, removable insertsare melted away under high heat. In additional embodiments, otherremovable inserts are removed from the base model as appropriate.

After complete removal of one or more removable inserts, what remains isthe base model connected to any non-removable inserts and any removableinserts that have not yet been removed. When fit together with the moldat this step, any volume(s) where feature(s) originally modeled by theremovable inserts that have now been removed will be empty. In one ormore embodiments this base model will contain invaginations in the spacewhere internal features originally modeled by removable inserts aredesired.

Each space is then filled with a material suitable for modeling thefeature up to the channel originally connecting it to the mold. In atleast one embodiment, at least one feature is created out of a differentdensity or color of the same material used in the base model. In otherembodiments, one or more features are made out of different materialsthan that used in the base model including silicone gels, hydrogels,plastics, rubbers, silicone rubbers, elastomers and composite materials.If any removable inserts are still present, they are sequentiallyremoved and filled as detailed in the last 3 paragraphs. Once allremovable inserts have been removed, each empty channel is filled withthe material originally used for the base model.

The resulting model, after finishing and clean up, contains an accuratephysical model created from a 3D computer model, which in embodimentsincludes features with different physical properties and made fromdifferent materials than the base model.

This embodiment consists of the creation of a model of a tumor inside akidney for use in practicing kidney tumor excision surgery. The inputdata consists of a computer model of a patient's kidney and a tumorinternal to the patient's kidney, which was derived from an MRI of thepatient processed using 3D Slicer©1.

The computer kidney and tumor models are combined, then subtracted froma large rectangular block in Tinkercad© (Autodesk, Inc. San Rafael,Calif.). Referring now to FIGS. 1-4, a channel 36 is added connectingthe internal cavity to the surface of the mold. The computer internaltumor insert piece 14 is placed inside the mold in its correct positionaccording to the input data. The tumor insert piece is connected to theoutside of the mold using channel 16, and the space where this channelpasses through the mold is subtracted from the mold creating theentrance 22. The mold is then split in two, resulting in two moldpieces, 10 and 11, and one insert piece consisting of 14 and 16.

The first mold piece, 10, contains part of the channel 22 that locks theinsert in place and will later be used to fill the space left by theremovable insert once it is removed. The second mold piece 11 alsocontains part of the channel 22 as well as the entirety of channel 36which will be used to fill the mold with the base material. These twomold pieces and the insert fit together as displayed in FIG. 4. Theinsert and mold computer model pieces are converted intoSTereoLithography (.stl) format and sliced using CURA to prepare fortheir manufacture by 3D printing.

The mold pieces 11 and 12 are then physically created using an Ultimaker2© (Ultimaker. Geldermalsen, Netherlands) 3D printer. These pieces are3D printed using the plastic PLA using manufacturer's instructions.Specifically, the PLA mold pieces were printed at a nozzle temperatureof 220 degrees Celsius with a base plate temperature of 75 degreesCelsius, 100% fan and using filament with a 2.85 mm diameter.

A first lining material, such as wax or petroleum jelly, e.g. Vaseline,may be smeared onto respective inner surfaces of the first mold pieces10 and the second mold piece 11.

The insert, comprised of 14 and 16, is printed separately in PVA at 190degrees Celsius with a base plate temperature of 75 degrees Celsius, and0% fan using filament with a 3 mm diameter.

Now referring to FIGS. 5-6, the physical mold pieces made from PLA, 10and 11, and the physical insert made from PVA, comprised of 14 and 16,are fitted together such that the channel of the insert 16 is placedinside the groove 22 creating a tight fit that positions the insertcorrectly inside the mold, matching the position of the patient's tumorin the input data. Next, the mold held together using clamps, tape, andrubber bands and/or adhesives as appropriate and then filled with amixture simulating the kidney. The simulated kidney material 23 used inthis embodiment is as follows:

A) 70% by volume Smooth-On platinum-cured silicone with a shore hardnessof 10 (Dragon Skin® 10A Fast, Smooth-On, Inc., Easton, Pa.).

B) 30% by volume Smooth-On Silicone Thinner (Silicone Thinner,Smooth-On, Inc., Easton, Pa.).

C) Addition of red and blue food dye until an appropriate color isachieved.

The mold is filled up to the bottom of the hole in the mold 36. In, somecases, the first lining material, e.g., wax or petroleum jelly, mayinhibit the simulated kidney material 23 from physical contact with themold pieces 11 and 12. After 90 minutes, giving the base model material40 time to harden, the base model 40 is delicately removed from the moldpieces 11 and 12, which can be discarded or set aside for future use.Referring now to FIGS. 7-9, the base material 23 is formed into a modelof the patient's kidney 40, containing a PVA insert 16 at the locationwhere the patient's tumor was observed in the original input data.

The insert inside the kidney model 40 is then removed by boiling inwater with heavy stirring for 2 hours, with frequent replacement of thewater for maximum efficiency. This process dissolves away the insert 16,creating a cavity 45 and a channel leading to the cavity 60 which existas empty space within the kidney model 40 as illustrated in FIGS. 10-11.

A second lining material, such as wax or petroleum jelly, e.g. Vaseline,may be smeared onto an inner surface of the kidney model 40.

Referring now to FIG. 12, the cavity 45 inside the kidney model isfilled with a material 42 simulating the patient's tumor, created inthis embodiment as follows:

A) 70% by volume Smooth-On platinum-cured silicone with a shore hardnessof 10 (Dragon Skin® 10A Fast, Smooth-On, Inc., Easton, Pa.).

B) 30% by volume Smooth-On Silicone Thinner (Silicone Thinner,Smooth-On, Inc., Easton, Pa.).

C) Addition of yellow and green food dye to achieve the desired color

D) Heavy stirring of all components for 7 minutes after initially mixedto introduce small air bubbles in the mixture.

As illustrated in FIG. 12, this mixture is added into the cavity 45,filling it to create the tumor model 72. In some cases, the secondlining material, e.g., wax or petroleum jelly, may inhibit the tumormodel 72 from physical contact with simulated kidney material 23.

At this stage the channel 60 unfilled. Finally, as illustrated in FIG.13, the channel 60 is filled with the same material used to simulate thekidney. This results in solid, lifelike, cut-able kidney model 40 withan internal tumor model 72 that can only be accessed by cutting open thekidney. The resulting model has been used for simulated surgeryapplications and is intended to constitute an anatomically accuratemodel of the patient's kidney and tumor to be used to practice removalof the patient's tumor prior to the patient's actual surgery.

The foregoing details the features of an embodiment of the invention sothat those skilled in the art may better understand the aspects of thepresent disclosure. Those skilled in the art should appreciate that theymay readily use the present disclosure as a basis for other devices andmodels that simulate natural biological tissue, including human tissue.In particular, the materials and methods of the present disclosure maybe readily used in any application where the simulation of human anatomyor organs, with or without additional features, is desired. Suchapplications include, but are not limited to, medical training devices,educational anatomy models, manikins, sex toys, puppets, costumes and/orother devices. Those skilled in the art should also realize that suchequivalent constructions do not depart from the spirit and scope of thepresent disclosure, and that they may make various changes,substitutions, and alterations to the embodiments disclosed hereinwithout departing from the spirit and scope of the present disclosure.Also, it will be fully appreciated that the above-disclosed features andfunctions, and variations thereof, may be combined into other methods,systems, apparatus, or applications.

What is claimed as the invention is:
 1. A method for producing ananatomical model, comprising: providing a mold assembly, comprising: afirst mold portion having an outer surface and an inner surface; and asecond mold portion having an outer surface and an inner surface;disposing a lining material on either a portion of the inner surface ofthe first mold portion or a portion of the inner surface of the secondmold portion, or both; forming a first cavity between the inner surfaceof the first mold portion and the inner surface of the second moldportion; positioning a portion of an insert in the first cavity, whereinthe insert has a protrusion having a portion disposed in a channelextending through either the first mold portion or the second moldportion, or both; introducing a first material into the first cavity;removing a portion of the insert to expose a second cavity inside themold assembly; and introducing a second material into the second cavity.2. The method of claim 1, further comprising introducing the firstmaterial through an opening extending through either the first moldportion or the second mold portion, or both.
 3. The method of claim 1,further comprising removing the portion of the insert through thechannel extending through either the first mold portion or the secondmold portion, or both.
 4. The method of claim 1, wherein a portion ofthe lining material inhibits curing a portion of the first material. 5.The method of claim 1, wherein a portion of the lining material bonds toa portion of the first material.
 6. The method of claim 1, wherein aportion of the lining material mixes or reacts with a portion of thefirst material.
 7. The method of claim 1, wherein a portion of thelining material dissolves a portion of the first material.
 8. The methodof claim 1, wherein a portion of the lining material is dissolved by aportion of the first material.
 9. The method of claim 1, wherein aportion of the lining material causes a portion of the first material toharden, soften, or change color.